Trial · NCT02242435

A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis

NCT02242435, Phase 3, Completed, Ampio Pharmaceuticals. Inc.; results first posted 2022-08-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis. Trials, record NCT02242435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02242435

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis
NCT number: NCT02242435
Status: Completed
Phases: Phase 3
Enrollment: 342 participants, actual
Lead sponsor: Ampio Pharmaceuticals. Inc.
Conditions: Osteoarthritis of the Knee
Interventions: 4 mL injection of Ampion, 4 mL Injection of Placebo
First posted: 2014-09-17
Last updated: 2022-09-15
Results first posted: 2022-08-29

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Knee Pain	Scored at Baseline and 20 Weeks	Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Secondary	Change in Knee Function	Scored at Baseline and 20 Weeks	Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Knee Pain	Scored at Baseline and 20 Weeks	Intent to Treat (ITT)	score on a scale	MEAN
SECONDARY	Change in Knee Function	Scored at Baseline and 20 Weeks	Intent to Treat (ITT)	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Knee Pain	Ampion 4 mL Injection	-0.96	95% Confidence Interval -1.09 to -0.82	score on a scale
Change in Knee Pain	Placebo 4 mL Injection	-1.10	95% Confidence Interval -1.24 to -0.95	score on a scale
Change in Knee Function	Ampion 4 mL Injection	-0.94	95% Confidence Interval -1.08 to -0.81	score on a scale
Change in Knee Function	Placebo 4 mL Injection	-1.08	95% Confidence Interval -1.22 to -0.94	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ampion 4 mL	172
Overall Study	STARTED	Placebo 4 mL	170
Overall Study	COMPLETED	Ampion 4 mL	152
Overall Study	COMPLETED	Placebo 4 mL	154
Overall Study	NOT COMPLETED	Ampion 4 mL	20
Overall Study	NOT COMPLETED	Placebo 4 mL	16

Source ClinicalTrials.gov

Adverse events84

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Ampion 4 mL	0	172
other	Nausea	Gastrointestinal disorders	Placebo 4 mL	4	170
other	Injection Site Bruising	General disorders	Ampion 4 mL	3	172
other	Injection Site Bruising	General disorders	Placebo 4 mL	3	170
other	Injection Site Pain	General disorders	Ampion 4 mL	11	172
other	Injection Site Pain	General disorders	Placebo 4 mL	10	170
other	Injection Site Swelling	General disorders	Ampion 4 mL	2	172
other	Injection Site Swelling	General disorders	Placebo 4 mL	3	170
other	Oedema Peripheral	General disorders	Ampion 4 mL	1	172
other	Oedema Peripheral	General disorders	Placebo 4 mL	4	170

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ampion 4 mL	0	172
Total, all-cause mortality	Placebo 4 mL	1	170
Total, other adverse events	Ampion 4 mL	107	172
Total, other adverse events	Placebo 4 mL	125	170
Total, serious adverse events	Ampion 4 mL	4	172
Total, serious adverse events	Placebo 4 mL	11	170

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ampion 4 mL vs Placebo 4 mL: deaths from any cause	Trial comparisons
Ampion 4 mL vs Placebo 4 mL: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02242435

GET https://conductscience.org/api/trials/v1/NCT02242435/events?page=2

API reference For AI assistants